RecruitingPhase 2NCT03290534
Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
Sponsor
CivaTech Oncology
Enrollment
40 participants
Start Date
Mar 13, 2019
Study Type
INTERVENTIONAL
Conditions
Summary
This is a feasibility study to determine the usefulness of a brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit lung cancer patients by reducing the radiation dose to critical structures, such as the heart wall, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.
Eligibility
Min Age: 18 Years
Inclusion Criteria10
- Subject signed inform consent
- Suspected or proven non-small cell lung cancer (NSCLC) in the upper lobes of the left or right lung
- Pre-operative criteria
- Lung nodule suspicious for NSCLC
- Mass ≤ 7 cm in maximum diameter by CT scan of the chest and upper abdomen
- Clinical stage I or Clinical stage II
- Not pregnant or nursing
- Negative pregnancy test in premenopausal women
- Fertile patients must use effective contraception
- More than 5 years since prior invasive malignancy unless non melanoma skin cancer or in-situ cancer
Exclusion Criteria1
- \-
Interventions
DEVICECivaSheet
implanting CivaSheet for localized radiation dose delivery
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03290534
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